Purpose :
The strength of clinical data needed for novel therapeutics to satisfy safety and efficacy thresholds for Food and Drug Administration (FDA) approval has long remained controversial. Although the traditional pre-market approval (PMA) process is the most stringent regulatory system in place worldwide, there remains significant weaknesses in the system. The continued development of new technologies invariably places strain on the the FDA’s limited resource capacity. We performed a retrospective, observational study to assess high risk device recalls, regulatory trends, and policy implications for the future.

Methods :
This IRB-exempt study utilized the FDA Center for Devices and Radiological Health database for Class I ophthalmic device recalls from 2003 to 2015. Approval data and recall characteristics were collected for each device. Additionally, reports of adverse events related to the manufacturer’s reason for recall were collected for each device using the FDA Manufacturer and User Facility Device Experience database.

Results :
Twelve Class I ophthalmic recall events were identified, constituting 68,820,497 total products (Figure 1). Nine out of 12 recalls resulted in at least one documented report of patient injury. Soft contact lenses, contact lens solution, and excimer laser systems were the most commonly recalled device classes. Six recalls occurred after 2011 (Figure 2). Five devices were cleared under the 510(k) pathway, 5 were cleared under the PMA pathway, 1 was exempt, and 1 was marketed without clearance. Three recalls were attributed to pre-market issues, 5 to post-market issues, and 4 were undetermined. An average of 5,735,041 devices were recalled per event and all but 2 devices had a worldwide distribution at the time of recall.

Conclusions :
It is important for ophthalmologists to understand recent high risk device recalls within their field as well as the current state of device regulation. Our results highlight the broad impact ophthalmic recall events have for both manufacturers and consumers. Although the absolute number of Class I recalls are low, the number of devices and patients affected extends to tens of millions. In the wake of recent legislation that further decreases evidence leading to device approval, policy makers must strive to maintain stringent approval and post-market surveillance standards in order to ensure patient safety and confidence.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.